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Senior Quality Assurance Analyst (Medical Compliance)

  • Kyiv, Ukraine
  • hot
Job #: 45215
Currently we are looking for a Senior Quality Assurance Analyst (Medical standards) for our Minsk office or Kiev office to make the team even stronger.

The successful candidate will join a team that designs, maintains and operates Quality Management System (QMS) for medical devices, which covers Hardware and Software medical devices. You will be managing global QMS processes for medical devices and implementing QMS for medical devices requirements in particular locations or projects.

Responsibilities

  • Study company rules, QMS for medical devices compliance approaches and procedures
  • Develop internal processes and policies for QMS for medical devices
  • Expand existing QMS for medical devices with new standards and regulations
  • Facilitate company teams and locations for internal and external audits independently
  • Conduct internal trainings in compliance area
  • Perform internal audits independently
  • Manage and/or assist customer or company QMS compliance requirements implementation
  • Support Sales teams with customer’s questions and audits in Medical compliance area
  • Implement the following standards: ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, parts of FDA and cGMP, customer’s medical requirements

Requirements

  • Several years’ experience working with QMS for medical devices. Working with Hardware medical devices is preferable
  • Experience with implementation or support or audit of QMS for medical devices or substantial set of processes related to QMS for medical devices
  • Strong knowledge/experience in any of the following frameworks: ISO 13485 or FDA requirements for medical device manufactures
  • Knowledge of/experience in any of the following standards: ISO 9001, 14971, 62304, IEC 62366-1, FDA/CFR parts, cGMP parts, etc
  • English B2 or higher
  • Good communication skills (readiness to communicate with people in multinational environment, ability to communicate orally and in writing explaining tasks, documentation, companies requirements)
  • Ready to learn including self-learning
  • Willingness to work in compliance area playing with big amount of policies, evidences and reports

Nice to have

  • Experience in development and performance of compliance program for Medical device manufacturer (gap analysis -> remediation plans -> detailing tasks, managing of tasks implementation -> internal audit)
  • Experience in Medical compliance audits
  • Certificates in Medical compliance area (ISO 13485, FDA, etc.)
  • English B2+ or higher

We offer

  • Innovative solutions delivery to the world’s digital changes
  • Experience exchange with colleagues all around the world
  • Opportunities for self-realization
  • Friendly team and enjoyable working environment
  • Engineering, corporate and social events
  • Social package: professional & soft skills trainings, medical & family care programs, sports
  • Free English classes
  • Flexible working schedule
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